Safety and Efficacy of Daratumumab in Combination With Ixazomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma (DARIA)
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|ClinicalTrials.gov Identifier: NCT03746652|
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Daratumumab, Ixazomib, Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multicenter, Open-label, Single-Arm Study to Evaluate the Safety and Efficacy of Daratumumab in Combination With Ixazomib and Dexamethasone as Second Line Therapy in Multiple Myeloma Patients Who Have Received Prior Treatment With a Lenalidomide Based Regimen|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Daratumumab, Ixazomib, Dexamethasone
Drug: Daratumumab, Ixazomib, Dexamethasone
Daratumumab 16 mg/kg, Ixazomib 4 mg, Dexamethasone 40 mg
- Overall Response Rate (ORR) [ Time Frame: From first day of treatment until end of study, documented progressive disease (PD), or death (approximately up to 36 months) ]ORR is defined as the proportion of patients who achieve a best response of PR or better, using modified IMWG criteria.
- Evaluation of the hematologic and non-hematologic toxicity profile of the combination. [ Time Frame: From first day of treatment until end of study, PD, or death (approximately up to 36 months) ]Toxicities related to the administration of Daratumumab or Ixazomib will be assessed (e.g., neutropenia, thrombocytopenia, nausea, peripheral neuropathy, rash, etc.).
- Duration of response (DOR) [ Time Frame: From the date of initial documentation of a response (CR, VGPR or PR) to the date of first documented evidence of PD, as defined in the IMWG criteria (approximately up to 36 months) ]For patients who have not progressed, data will be censored at the last disease evaluation before the start of any subsequent anti-myeloma therapy.
- Time to disease progression (TTP) [ Time Frame: From C1D1 to the date of first documented evidence of PD, as defined in the IMWG criteria (approximately up to 36 months) ]Time in months from first dose of treatment until PD.
- Progression-free survival (PFS) [ Time Frame: From C1D1 to either PD, according to the IMWG criteria, or death, whichever occurs first (approximately up to 36 months) ]For patients who have not progressed and are alive, data will be censored at the last disease evaluation before the start of any subsequent anti-myeloma therapy. Relapse from CR by positive immunofixation or trace amount of M-protein is not considered to be PD and is not included in the PFS calculation.
- Overall survival (OS) [ Time Frame: From C1D1 to the date of death from any cause (approximately up to 36 months) ]Overall survival (OS) is measured from C1D1 to the date of the patient's death. If the patient is alive or the vital status is unknown at the time of the analysis, then the patient's data will be censored at the date the patient was last known to be alive.
- Time to next therapy (TNT) [ Time Frame: From C1D1 to the date of the next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 36 months) ]For patients who neither start a new anti-neoplastic therapy nor die, survival time will be censored at the date of their last available follow-up date. For a patient who does not have any post-baseline follow-up assessments and who has not died, survival time will be censored at C1D1.
- Minimal Residual Disease (MRD) negativity using Next-Generation Flow Cytometry (NGFC) [ Time Frame: Assessed every 3 months post CR/sCR until PD (approximately up to 36 months) ]MRD negativity rate is defined as the proportion of patients who achieve a negative result of MRD. Patients without MRD assessment will be considered as having MRD-positive results.
- Serum bone markers [ Time Frame: The evaluation will be performed on C1D1 and then every 3 months until PD (approximately up to 36 months) ]NTX, CTX, bALP, RANKL, OPG, Dkk-1, SOST and serum angiogenic cytokines levels angiogenin, VEGF, angiopoietin-1 and -2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746652
|Contact: Panayiotis Panayiotidis, Prof.||+firstname.lastname@example.org|
|General Hospital of Athens "Alexandra"||Not yet recruiting|
|Athens, Attica, Greece, 11528|
|Contact: Evangelos Terpos, Prof. +302103381512|
|Principal Investigator:||Evangelos Terpos, Prof.||Department of Clinical therapeutics, National and Kapodistrian University of Athens, School of medicine, Athens, Greece|